August 25, 2011

Del Monte Fresh Produce Inc. has sued the U.S. Food and Drug Administration, objecting to agency restrictions on imported cantaloupe from Guatemala after an outbreak of Salmonella.

In an unusual challenge, Del Monte in a suit filed earlier this week in Maryland federal court alleges that the FDA never properly determined that cantaloupe-much less cantaloupe from its supplier in Guatemala—was responsible for food poisoning that sickened 20 people in 10 states in March and April.

The FDA’s cantaloupe import restrictions are “based on an erroneous speculative assumption, unsupported by evidence,” according to the complaint, filed on Aug. 22 by McKenna Long & Aldridge partner Daniel Jarcho and associate Alanna Clair.

On March 22, Del Monte voluntarily recalled 4,992 cartons of the melon “because they have the potential to be contaminated with Salmonella Panama,” according to the FDA recall notice. The pathogen, an uncommon strain, causes fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain, and, more rarely, severe illnesses such as arterial infections.

After the recall, the company was promptly sued by food poisoning litigator Bill Marler of Marler Clark on behalf of a 12-year old girl in Colorado who was allegedly sickened by contaminated cantaloupe.

“Del Monte had a responsibility to provide its customers with safe, healthy, unadulterated cantaloupe,” Marler said in an April 1 new release announcing the suit, filed in Adams County District Court in Colorado. “Kids should not land in the hospital because they choose to eat fruit instead of processed foods.”

The FDA in July issued a follow-up “import alert” on cantaloupe from a farm in Asuncion Mita, Guatemala. The farm, which supplies Del Monte with 27% of its cantaloupe, was identified as the source of the contaminated melon. Consumers bought the melons at Costco, which traced them to the grower.

The FDA concluded that it was “extremely unlikely” that the Salmonella was due to an isolated event at the farm, instead blaming water contaminated with sewage, poor hygienic practices of workers, animals in close proximity to product or water sources, and/or lack of adequate cleaning and sanitizing of equipment.

As a result of the import alert, shipments from the farm are subject to “Detention Without Physical Examination,” pending proof that they are pathogen-free. But since cantaloupe can only be stored in a warehouse for 14 days (and preferably no more than seven), any delay at the border is problematic for Del Monte.

According to Del Monte, cantaloupe are being unfairly blamed, and that the “FDA did not have, and never has had, evidence that cantaloupes from Asuncion Mita caused the Salmonella illness.”

In the complaint, Del Monte said it only agreed to the limited recall in March because it feared that if it refused, the FDA would issue a general advisory that would “potentially affect the entire cantaloupe market.”

After the recall, Del Monte said it hired third party experts to inspect the farm and test the cantaloupe. The inspectors found the farm was sanitary and that no Salmonella was present on any melons.

Del Monte alleges that the FDA never actually tested any cantaloupe associated with the original outbreak, and that the agency’s own subsequent Salmonella tests on Asuncion Mita melons have all been negative.

Also, the company says the FDA hasn’t accounted for evidence indicating the illness wasn’t even caused by cantaloupe. For example, one patient denied consuming the fruit. Del Monte additionally claims the FDA never considered that the bad cantaloupe could have come from another supplier, or that the contamination might have occurred at the retail level.

The company wants the court to force the FDA to lift the import restriction because it is arbitrary and capricious and exceeds the FDA’s statutory jurisdiction.

Blame it on Grover Norquist. If his lockstep Republicans would desist from trying to starve the federal government, maybe the FDA could conduct more thorough investigations. Failing that, the default response must be in favor of food safety.